GAO: FDA Needs to Probe Deeper into Device Recalls

WASHINGTON -- Medical device firms recall about 700 unsafe or faulty medical devices per year, but the FDA is not doing a good job of analyzing the reasons for so many recalls, according to a new report from the Government Accountability Office (GAO).

The GAO investigators chided the FDA for missing the opportunity to explain trends in device recalls because of the agency's lack of a comprehensive recall analysis strategy. The agency doesn't look at the bigger picture of why devices are taken off the market and what can be done to make the device approval and monitoring system safer, GAO investigators said.

"The agency has a plethora of data available on thousands of recalls, but at present, is not effectively reviewing and analyzing these data in a systematic manner," the authors of the GAO report concluded. "More routine analyses of these data could help FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls."

Sens. Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.), who requested the report, said the report shows the FDA needs to do a better job at assessing device recalls to "better mitigate the risk of serious health consequences from defective or unsafe devices."

"Right now, it looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices," Grassley said in a press release. "Doing so would establish greater accountability for patients."

A preliminary version of the report was unveiled at an April hearing of the Senate Special Committee on Aging, and it also criticized the FDA for not keeping track of the reasons a device was recalled.

The updated report found that from 2005 through 2009, medical device companies initiated 3,510 device recalls, averaging just over 700 per year.

Most of the recalls -- 2,773 of them -- dealt with devices approved through the FDA's fast-track 510(k) approval process, which is responsible for approving more than 90% of all FDA-cleared devices. The process allows device makers to show their product is similar to one already on the market, and saves them the time and costs involved in the process of conducting clinical trials in humans.

Critics have attacked the 510(k) process from both sides. Patient safety groups have called it irresponsible to rush medical devices through without ever testing them in humans, while those in the device industry say the FDA is too slow to approve devices, and, as a result, device makers are seeking approval first in Europe.

Most of those recalls were classified as class II, meaning the use of the recalled device carried a moderate health risk. How the FDA classifies its recalls has come under fire from some patient groups that think the FDA uses class II recalls when really the recall should be a class III.

Take the case of a Denver woman who was born with a disease that caused her extreme hip pain once she hit her 30s. She received a DePuy ASR prosthetic hip in 2006, but the hip was recalled in 2010 after it was found to malfunction at a much higher rate than expected. In Korgaokar's case, the metal implant's excessive wear and tear released levels of cobalt and chromium in her body that were 1,000% higher than normal.

That recall was judged by the FDA to be just "moderate risk." But Korgaokar had to undergo additional painful surgeries to remove the hip, have a new one implanted, and she said the device malfunction may have caused her to miss her window to have children.

Just 4% of the devices recalled were classified as class I recalls by the FDA, meaning there's a good chance that use of the product would cause serious adverse health consequences or death. In some cases, the FDA did not consistently inspect the manufacturing establishments of firms issuing the most dangerous type of recalls.

Just over 40% of the recalls were for cardiovascular, radiological, or orthopedic devices.

The most common reason for a recall was "problems with manufacturing processes." At least, that was the main reason in 2008 and 2009, the only years the agency tracked underlying reasons for recalls.

Generally, the firm that makes the device initiates a recall after receiving reports of safety problems and is responsible for alerting the FDA and users of the device about the recall. The FDA is responsible for terminating the recall, which it's supposed to do within three months. But in more than half of all recalls, the FDA missed that deadline. The average device recall lasted 192 days.

"If unaddressed by FDA, the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market," the GAO report concluded.

In its response to the report, the Department of Health and Human Services (HHS) "agreed with our conclusions and recommendations and stated that the agency is committed to exploring each of our recommendations fully," the report authors noted.

"HHS reported that FDA plans to convene a working group to both evaluate improvements to the recall process and to develop strategies to implement our recommendations ... We are greatly encouraged by the agency's response and believe its expeditious implementation of the recommendations will serve to enhance the safety of medical devices used by millions of Americans each day."